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Corstasis Therapeutics Inc. took inspiration from Narcan when coming up for its own nasal spray.
“It got me thinking, ‘What could we potentially repurpose into a nasal spray for cardiology?’” Chief Executive Benjamin “Ben” Esque told the Business Journal.
For five years, the clinical-stage pharmaceutical company has developed Enbumyst, a nasal spray intended to remove excess body fluid associated with congestive heart failure, as well as liver and kidney disease.
Corstasis received Food and Drug Administration acceptance of its New Drug Application for Enbumyst in January. The FDA is set to complete its review process of the company’s application on Sept. 14.
Esque, a former executive at Edwards Lifesciences, said that the company’s goal is to be launch ready about a month after the date, assuming it gets approval.
While Corstasis is based in Henderson, Nevada, Esque lives and works out of Huntington Beach.
Chief Medical Officer Dr. Brian Kolski is also local and leads the structural heart disease department at Providence St. Joseph Hospital.
New Outpatient Therapeutic Option
The company motto is “home is where the heart is.”
“Our goal is to keep people out of the hospital,” Esque said.
Congestive heart failure occurs when the heart doesn’t pump out enough blood, causing fluids to accumulate in the arms, legs, lungs and other organs.
Because of this, patients with congestive heart failure often have to take an oral diuretic medication to increase urine output and reduce fluid buildup in the body.
Some patients, however, don’t respond well to the drug and end up having their dosages doubled or tripled, resulting in them becoming resistant to the oral diuretic, Esque said.
These patients are then admitted to the hospital for an intravenous version of the same drug with 80% being discharged with incomplete removal of excess fluids, according to Corstasis.
“We think a big part of this problem is the fact that the patient wasn’t fully dried out when they were discharged from the hospital, and this highly likely to be back in the hospital within 30 days,” Esque said.
Corstasis developed Enbumyst to prevent hospitalizations from happening in the first place.
“The intent here is to bypass the gut through the nose,” Esque said.
Data from a clinical trial comparing Enbumyst to oral and IV formulations was published last year in cardiology journal Circulation. Results found the nasal spray to have equivalent effectiveness.
It takes about 30 minutes for the spray to kick in, about 35% faster than oral treatments, according to Esque.
The company’s advisory board includes Roger Crystal, founder of Opiant Pharmaceuticals Inc. which invented Narcan nasal spray for reversing opioid overdoses.
Former Edwards Sales Training Exec
Esque’s background is largely in commercialization and development of cardiovascular medical devices and pharmaceuticals.
He began his nearly 20-year career in interventional cardiology at Cordis, where he was promoted from a senior sales representative to run global training.
Esque left Cordis in 2012 for Edwards where he helped design the physician and sales training for the U.S. commercial launch of the Sapien line of transcatheter heart valves.
“I went all around the world, met all kinds of world experts and I wanted to really get back out in the field,” Esque said.
This drove him to San Diego-based Abiomed Inc., a portfolio company of Johnson & Johnson.
It was at Abiomed that he met Dr. Kolski, and they came up with the idea for a diuretic nasal spray.
Esque invested his own money to create a formulation, then was able to raise roughly $20 million from local cardiologists and other investors interested in using the product.
“What once started as a crazy idea is now a product that has been tested effectively in humans,” Esque said.